Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1

This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 and
varying antibody masses of MVT-5873. The study is designed to identify an optimal dose (total
antibody mass) and optimal timing, for tumor imaging using PET scanning. This trial will
include a dose escalation and an expansion phase. During the dose escalation portion of the
study, a determination of the optimal time to perform PET imaging will be made. Following the
identification of the "optimal" dose and timing, an 10 additional subjects will be imaged
using the best dose and timing.

In each portion of the study subjects will have a screening visit and, no more than 28 days
later, those who are eligible for the study will receive MVT-2163. Each cohort will have 3-6
subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1. Subjects in
cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10 minutes later by
MVT-2163. Subjects will return for visits to the clinic on days 2, 4, and 7 for additional
imaging and safety assessments. A follow-up visit will occur on day 28.

The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163 and,
based on these data, the study will estimate the radiation dosimetry of MVT-2163. Safety
assessments will be performed using ECGs, vital signs measurements, assessments of
performance status, and clinical laboratory measurements.

Inclusion Criteria:

- Signed, informed consent

- Histologically confirmed, locally-advanced or metastatic pancreatic ductal
adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive
malignancies

- At least one lesion by CT or MRI ≥ 2 cm

- ECOG performance status of 0 to 2

- Absolute neutrophil count ≥1.50 x 109/L

- Hemoglobin ≥ 9.0 g/dL (in the absence of red blood cell transfusions in the prior 14
days)

- Platelet count >75,000/ mm3

- AST/SGOT, ALT/SGPT ≤2.5 x ULN, unless liver metastases are clearly present, then ≤5.0
x ULN

- Total bilirubin <1.5x the upper limit of normal unless considered due to Gilbert's
syndrome in which case, <3x the upper limit of normal

- Serum creatinine (serum or plasma) ≤ 1.5 x ULN or GFR>50 mL/min

- Serum albumin > 3.0g/dL

- Willingness to participate in collection of pharmacokinetic samples

- Willingness to use adequate contraception throughout study and for a period of 90 days
last dose of study drug

Exclusion Criteria:

- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy

- Major surgery other than diagnostic surgery within 28 days

- History of anaphylactic reaction to human, or humanized, antibody

- Other on-going cancer therapy or investigational agents (except MVT-5873 )

- Known history of HIV or Hepatitis C

- Pregnant or currently breast-feeding

- Psychiatric illness/social situations that would interfere with compliance with study
requirements

- Significant cardiovascular risk including, but not limited to, recent (within 28 days)
coronary stenting or myocardial infarction within 6 months